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Phase 3Recruiting

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Sponsor
89bio, Inc. (Industry)
Enrolment
1,350 planned
Conditions
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Interventions
Pegozafermin; Placebo
Ages
adults, older adults
Registry
NCT06318169

Full record on ClinicalTrials.gov

From the registry

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Primary outcomes

  • Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52
  • Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52
  • Time to First Occurrence of Disease Progression

History

  1. Primary completion expected

  2. Last registry update

  3. Registered

  4. Started